Pletaal SR Post Marketing Observational Study (PLT SR PMOS)
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ClinicalTrials.gov Identifier: NCT01782833
Verified January 2013 by Korea Otsuka Pharmaceutical Co., Ltd.. Recruitment status was: Not yet recruiting
This is a Post Marketing Observational Study of cilostazol (Pletaal® SR capsule). As this study is observational in nature to collect the safety data after administrating the Pletaal SR capsule, from baseline to 16 weeks.
Condition or disease
Treatment of Ischemic Symptom and Prevention of Recurrence of Cerebral Infarction
This study will be conducted in a prospective, single-arm, multi-center format. As this study is observational in nature, the patient's follow-up is not prescriptive in nature and must be left up to the judgment of the physician (investigator), within the period of observation set forth in the protocol.
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Ages Eligible for Study:
19 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
The patient who has below indication (1. Treatment of ischemic symptoms including ulceration, pain and coldness in chronic arterial occlusion (Berger's disease, arteriosclerosis obliterans, diabetic peripheral angiopathy). 2. Prevention of recurrence of cerebral infarction (excluding cardiogenic cerebral embolism).)
- Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study : 1. Patients who are prescribed Pletaal® SR capsule treatment as per investigator's medical judgment for adults aged 19 and over.
2. Patients who gave written authorization to use their personal and health data Physician (Investigator) will refer to the product market authorization (package insert) for inclusion criteria.
Patients presenting with any of the following will not be included in the study 1. Patients with hemorrhage 2. Patients with congestive heart failure 3. Patients with known hypersensitivity to Cilostazole or any ingredients of Pletaal® 4. Women who are pregnant or may possibly become pregnant 5. Patients who is not eligible to participate this study as investigator's medical judgment Physician (Investigator) will refer to the product market authorization (package insert) for exclusion criteria.